BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LayZir Disc

    DI: D952CM0034 · Model: CM0034S · SMART DENTISTRY SOLUTIONS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    LayZir Disc
    Primary DI
    D952CM0034
    Version / Model
    CM0034S
    Catalog Number
    CM0034S
    Company Name
    SMART DENTISTRY SOLUTIONS INC.
    Labeler DUNS
    112861098
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-06-16
    Public Version
    1
    Public Version Date
    2020-06-24
    Public Version Status
    New
    Public Device Record Key
    fe8e6704-1576-4ae5-9ed8-5239bdb7334e

    Device Description

    LayZir isc AD98-25-LZ A2

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    EIH Powder, Porcelain

    GMDN Terms

    Code Name
    16187 Dental appliance fabrication material, ceramic

    Identifiers

    Type ID
    Primary D952CM0034

    Customer Contacts

    Phone
    949-446-9383
    Email
    [email protected]